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Homeopathic Ear Drops for Otitis Media Study

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 28, 2009
Last Update Posted: July 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
James Taylor, University of Washington
The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media in whom the health care provider has recommended that antibiotics not be immediately administered. A total of 150 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.

Condition Intervention
Otitis Media Drug: Hyland's earache drops

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Homeopathic Ear Drops for Children With Otitis Media Study

Resource links provided by NLM:

Further study details as provided by James Taylor, University of Washington:

Primary Outcome Measures:
  • Severity of Symptoms of Otitis Media [ Time Frame: 15 days ]
  • Administration of Antibiotics [ Time Frame: 15 days ]
    Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit.

Secondary Outcome Measures:
  • Side Effects From Study Remedy [ Time Frame: 15 days ]
    Any "other symptoms" reported by parents in logbooks. Logbooks were returned by 72/105 participants randomized to the homeopathic ear drops group and 78 of those randomized to standard therapy alone.

Enrollment: 210
Study Start Date: October 2009
Study Completion Date: December 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Homeopathic ear drops
Commercially available homeopathic ear drops
Drug: Hyland's earache drops
3-4 drops in affected ear 3 times a day as needed for up to 5 days
No Intervention: standard therapy
standard therapy for otitis media, no ear drops


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   6 Months to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 6 months - 11 years old
  • Diagnosed with otitis media by clinician at participating clinic
  • Clinician determines that a "watch and wait" antibiotic prescription treatment plan is optimal management

Exclusion Criteria:

  • Antibiotic treatment during past 7 days
  • Homeopathic treatment within past 30 days
  • History of serious chronic illness (e.g. diabetes, autoimmune disease, cystic fibrosis
  • Perforated tympanic membrane
  • Immediate antibiotic treatment plan decided by examining clinician
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003210

United States, Washington
Mercer Island Pediatric Associates
Mercer Island, Washington, United States, 98040
Valley Children's Clinic
Renton, Washington, United States, 98055
University of Washington Medical Center-Roosevelt Pediatric Care Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Principal Investigator: James A Taylor, MD University of Washington
  More Information

Responsible Party: James Taylor, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01003210     History of Changes
Other Study ID Numbers: 37011-B
First Submitted: October 26, 2009
First Posted: October 28, 2009
Results First Submitted: May 19, 2014
Results First Posted: July 22, 2014
Last Update Posted: July 30, 2014
Last Verified: July 2014

Keywords provided by James Taylor, University of Washington:
otitis media

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases